Cognitive DisorderPhase 1NCT03031574
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects
A Phase 1 study testing SUVN-D4010 in people with Cognitive Disorder, run by Suven Life Sciences Limited at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Disorder
- What is being tested?
- SUVN-D4010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 7 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
- Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.
Who cannot join
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
- Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
- Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
- As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects
The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.
Read the detailed description
The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.
- Conditions
- Cognitive Disorder
- Being tested
- SUVN-D4010
- Keywords
- Serotonin 4 (5-HT4) receptor, Phase 1
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUVN-D4010Drug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Food Effect | Active comparator | SUVN-D4010 tablets single dose Receives: Drug: SUVN-D4010 |
| Gender Effect | Active comparator | SUVN-D4010 tablets single dose Receives: Drug: SUVN-D4010 |
| Age Effect | Active comparator | SUVN-D4010 tablets single dose Receives: Drug: SUVN-D4010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration (AUC)
Measured: 72 hours
Maximum observed concentration (Cmax)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start23 Jan 2017
- Primary completion29 Aug 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suven Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Dickerson, MD, PhD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031574
- Sponsor's protocol ID
- CTP1S240105HT4
- Status last verified
- Sep 2017
- First submitted
- 23 Jan 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.
PubMed 33788154
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03031574
- Acronym / sponsor ID
- CTP1S240105HT4
- Conditions
- Cognitive Disorder
- Keywords
- Serotonin 4 (5-HT4) receptor, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.
Detailed description
The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food Effect | Active comparator | Drug: SUVN-D4010SUVN-D4010 tablets single dose |
| Gender Effect | Active comparator | Drug: SUVN-D4010SUVN-D4010 tablets single dose |
| Age Effect | Active comparator | Drug: SUVN-D4010SUVN-D4010 tablets single dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
- Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.
Key exclusion criteria (5 listed)
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
- Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
- Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
- As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUVN-D4010Tablets | Drug | Age Effect, Food Effect, Gender Effect |
Primary outcome
Area under concentration (AUC)
Time frame: 72 hours
Maximum observed concentration (Cmax)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 33788154Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Dickerson, MD, PhD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SUVN-D4010 in people with Cognitive Disorder, run by Suven Life Sciences Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration (AUC) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.